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FDA 510(k)

GUARDIAN SURGEON'S GOWNS

K-Number: K931562 · 1994-10-07

ApplicantAtkins Healthcare Services
Decision Date1994-10-07
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GUARDIAN SURGEON'S GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Atkins Healthcare Services. It received FDA 510(k) clearance on 1994-10-07 under 510(k) number K931562. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUARDIAN SURGEON'S GOWNS?

GUARDIAN SURGEON'S GOWNS is a medical device that received FDA 510(k) clearance on 1994-10-07. The listed applicant is Atkins Healthcare Services. The 510(k) number is K931562.

When did GUARDIAN SURGEON'S GOWNS receive FDA 510(k) clearance?

GUARDIAN SURGEON'S GOWNS received FDA 510(k) clearance on 1994-10-07, under 510(k) number K931562.

Who is the listed applicant for GUARDIAN SURGEON'S GOWNS?

The FDA 510(k) record lists Atkins Healthcare Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUARDIAN SURGEON'S GOWNS?

The FDA product code for GUARDIAN SURGEON'S GOWNS is FYA.

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Related Devices (Code: FYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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